A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer, Dukes Stage C.
1 other identifier
interventional
228
1 country
46
Brief Summary
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 colorectal-cancer
Started Jul 2007
Longer than P75 for phase_4 colorectal-cancer
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 17, 2007
CompletedFirst Posted
Study publicly available on registry
July 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
September 3, 2015
CompletedSeptember 3, 2015
August 1, 2015
4.7 years
July 17, 2007
August 6, 2015
August 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as \[number of participants with event divided by number analyzed\] multiplied by 100.
Up to 25 weeks (from Baseline to the end of safety follow-up)
Secondary Outcomes (1)
Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE
Up to 25 weeks (from Baseline to the end of safety follow-up)
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- colon cancer (Dukes stage C);
- surgery, with no evidence of remaining tumor;
- ECOG performance status of \<=1.
You may not qualify if:
- previous therapy for currently treated colon cancer;
- any evidence of metastatic disease;
- history of other malignancy within last 5 years;
- clinically significant cardiac disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Unknown Facility
Arkhangelsk, 163045, Russia
Unknown Facility
Astrakhan, 414041, Russia
Unknown Facility
Barnaul, 656049, Russia
Unknown Facility
Belgorod, 308010, Russia
Unknown Facility
Chelyabinsk, 454047, Russia
Unknown Facility
Irkutsk, 664035, Russia
Unknown Facility
Izhevsk, 426009, Russia
Unknown Facility
Kaluga, 248007, Russia
Unknown Facility
Kazan', 420029, Russia
Unknown Facility
Kazan', 420111, Russia
Unknown Facility
Kirov, 610021, Russia
Unknown Facility
Kostroma, 156005, Russia
Unknown Facility
Krasnodar, 350040, Russia
Unknown Facility
Kursk, 305035, Russia
Unknown Facility
Lipetsk, 398005, Russia
Unknown Facility
Moscow, 105229, Russia
Unknown Facility
Moscow, 107005, Russia
Unknown Facility
Moscow, 119992, Russia
Unknown Facility
Moscow, 123354, Russia
Unknown Facility
Moscow, 127006, Russia
Unknown Facility
Moscow, 143420, Russia
Unknown Facility
Nizhny Novgorod, 603126, Russia
Unknown Facility
Novgorod Veliky, 173016, Russia
Unknown Facility
Obninsk, 249036, Russia
Unknown Facility
Orenburg, 460021, Russia
Unknown Facility
Perm, 614 066, Russia
Unknown Facility
Rostov-on-Don, 344037, Russia
Unknown Facility
Ryazan, 390011, Russia
Unknown Facility
Saint Petersburg, 197022, Russia
Unknown Facility
Saint Petersburg, 197047, Russia
Unknown Facility
Salekhard, 629001, Russia
Unknown Facility
Samara, 443031, Russia
Unknown Facility
Sashi, 354057, Russia
Unknown Facility
Smolensk, 214000, Russia
Unknown Facility
Stavropol, 355047, Russia
Unknown Facility
Surgut, 628408, Russia
Unknown Facility
Tollyatti, 445846, Russia
Unknown Facility
Tomsk, 634028, Russia
Unknown Facility
Tomsk, 634050, Russia
Unknown Facility
Tver', 170008, Russia
Unknown Facility
Tyumen, 625047, Russia
Unknown Facility
Ufa, 450005, Russia
Unknown Facility
Ufa, 450054, Russia
Unknown Facility
Volgograd, 400138, Russia
Unknown Facility
Yekaterinburg, 620905, Russia
Unknown Facility
Yuzhno-Sakhalinsk, 693010, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2007
First Posted
July 18, 2007
Study Start
July 1, 2007
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
September 3, 2015
Results First Posted
September 3, 2015
Record last verified: 2015-08